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A Replication-Defective Herpes Simplex Virus (HSV)-2 Vaccine, HSV529, is Safe and Well-Tolerated in Adults with or without HSV Infection and Induces Significant HSV-2-Specific Antibody Responses in HSV Seronegative Individuals
Abstract Background We conducted a phase 1, randomized, double-blind, placebo-controlled trial of a replication-defective HSV-2 vaccine, HSV529 (deleted for UL5 and UL29), in 60 healthy adults aged 18 to 40 years. Methods Subjects were enrolled in groups of 20 from 3 serogroups: HSV1+ or -/HSV2+ (g...
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Published in: | Open forum infectious diseases 2017-10, Vol.4 (suppl_1), p.S415-S416 |
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creator | Dropulic, Lesia Wang, Kening Oestreich, Makinna Pietz, Harlan Garabedian, Doreen Jegaskanda, Sinthujan Dowdell, Kennichi Nguyen, Hanh Laing, Kerry Koelle, David Azose, Aaron Hunsberger, Sally Lumbard, Keith Chen, Aiying Chang, Lee-Jah Phogat, Sanjay Cohen, Jeffrey |
description | Abstract
Background
We conducted a phase 1, randomized, double-blind, placebo-controlled trial of a replication-defective HSV-2 vaccine, HSV529 (deleted for UL5 and UL29), in 60 healthy adults aged 18 to 40 years.
Methods
Subjects were enrolled in groups of 20 from 3 serogroups: HSV1+ or
-/HSV2+ (group 1), HSV1+/HSV2– (group 2), and HSV1-/HSV2– (group 3). At months 0, 1, and 6, 15 subjects in each group received HSV529 intramuscularly and 5 subjects received placebo. The primary endpoint was the frequency of solicited injection site and systemic reactions from day 0 to 7 after each vaccination and unsolicited adverse events up to 6 months after the last dose.
Results
89% of vaccine recipients experienced a mild to moderate solicited injection site reaction vs. 47% of placebo recipients (P = 0.006, 95% CI 0.129, 0.676) that did not preclude additional doses. 64% of vaccine recipients experienced solicited systemic reactions vs. 53% of placebo recipients (P = 0.44, 95% CI -0.179, 0.402). Two serious adverse events occurred in 2 participants and were assessed as unrelated to HSV529 administration. Serum neutralizing antibody titers significantly increased from baseline after 3 doses of HSV529 compared with placebo in group 3 only (P < 0.001). This increase persisted up to 6 months after the third dose of vaccine (P < 0.001). Serum and vaginal antibodies to HSV2 glycoprotein D (gD) also significantly increased after 3 doses of vaccine in group 3 subjects (P < 0.001 and P = 0.012, respectively). The mean vaginal gD titer after 3 doses was about one-third of the mean serum gD titer. In addition, the vaccine induced significant levels of HSV2-specific antibody dependent cellular cytotoxicity (ADCC) after 3 doses in group 3 subjects compared with placebo (P < 0.001). Vaccine-induced CD4 T-cell responses were detected in 46%, 27%, and 36% of subjects in groups 1, 2, and 3, respectively, one month after the third dose of vaccine. CD8 T-cell responses were detected in 8%, 18%, and 14% of subjects in groups 1, 2, and 3, respectively, at the same time point.
Conclusion
The HSV529 vaccine was safe, well-tolerated, and immunogenic, eliciting significant neutralizing, gD, and ADCC-mediating antibodies, and modest cellular immune responses in HSV seronegative individuals. NCT01915212
Disclosures
L. Dropulic, sanofi pasteur: Collaborator, Research support; K. Wang, sanofi pasteur: Collaborator, Research support; M. Oestreich, sanofi pasteur: Collaborator, Research support; |
doi_str_mv | 10.1093/ofid/ofx163.1041 |
format | article |
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Background
We conducted a phase 1, randomized, double-blind, placebo-controlled trial of a replication-defective HSV-2 vaccine, HSV529 (deleted for UL5 and UL29), in 60 healthy adults aged 18 to 40 years.
Methods
Subjects were enrolled in groups of 20 from 3 serogroups: HSV1+ or
-/HSV2+ (group 1), HSV1+/HSV2– (group 2), and HSV1-/HSV2– (group 3). At months 0, 1, and 6, 15 subjects in each group received HSV529 intramuscularly and 5 subjects received placebo. The primary endpoint was the frequency of solicited injection site and systemic reactions from day 0 to 7 after each vaccination and unsolicited adverse events up to 6 months after the last dose.
Results
89% of vaccine recipients experienced a mild to moderate solicited injection site reaction vs. 47% of placebo recipients (P = 0.006, 95% CI 0.129, 0.676) that did not preclude additional doses. 64% of vaccine recipients experienced solicited systemic reactions vs. 53% of placebo recipients (P = 0.44, 95% CI -0.179, 0.402). Two serious adverse events occurred in 2 participants and were assessed as unrelated to HSV529 administration. Serum neutralizing antibody titers significantly increased from baseline after 3 doses of HSV529 compared with placebo in group 3 only (P < 0.001). This increase persisted up to 6 months after the third dose of vaccine (P < 0.001). Serum and vaginal antibodies to HSV2 glycoprotein D (gD) also significantly increased after 3 doses of vaccine in group 3 subjects (P < 0.001 and P = 0.012, respectively). The mean vaginal gD titer after 3 doses was about one-third of the mean serum gD titer. In addition, the vaccine induced significant levels of HSV2-specific antibody dependent cellular cytotoxicity (ADCC) after 3 doses in group 3 subjects compared with placebo (P < 0.001). Vaccine-induced CD4 T-cell responses were detected in 46%, 27%, and 36% of subjects in groups 1, 2, and 3, respectively, one month after the third dose of vaccine. CD8 T-cell responses were detected in 8%, 18%, and 14% of subjects in groups 1, 2, and 3, respectively, at the same time point.
Conclusion
The HSV529 vaccine was safe, well-tolerated, and immunogenic, eliciting significant neutralizing, gD, and ADCC-mediating antibodies, and modest cellular immune responses in HSV seronegative individuals. NCT01915212
Disclosures
L. Dropulic, sanofi pasteur: Collaborator, Research support; K. Wang, sanofi pasteur: Collaborator, Research support; M. Oestreich, sanofi pasteur: Collaborator, Research support; H. Pietz, sanofi pasteur: Collaborator, Research support; D. Garabedian, sanofi pasteur: Collaborator, Research support; K. Dowdell, sanofi pasteur: Collaborator, Research support; H. Nguyen, sanofi pasteur: Collaborator, Research support; K. Laing, sanofi pasteur: Research Contractor, payment for conducting T cell assays; D. Koelle, sanofi pasteur: Research Contractor, payment for conducting T cell assays; A. Azose, sanofi pasteur: Research Contractor, Payment for conducting T cell assays; A. Chen, sanofi pasteur: Employee, Salary; L. J. Chang, sanofi pasteur: Employee, Salary; S. Phogat, sanofi pasteur: Employee, Salary</description><identifier>ISSN: 2328-8957</identifier><identifier>EISSN: 2328-8957</identifier><identifier>DOI: 10.1093/ofid/ofx163.1041</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Abstracts</subject><ispartof>Open forum infectious diseases, 2017-10, Vol.4 (suppl_1), p.S415-S416</ispartof><rights>The Author 2017. Published by Oxford University Press on behalf of Infectious Diseases Society of America. 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2211-488c3376c87379e11947ec9c3315f8738f0846b86054c7caf43f3c1ab5133a3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5630753/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5630753/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,1604,27924,27925,53791,53793</link.rule.ids></links><search><creatorcontrib>Dropulic, Lesia</creatorcontrib><creatorcontrib>Wang, Kening</creatorcontrib><creatorcontrib>Oestreich, Makinna</creatorcontrib><creatorcontrib>Pietz, Harlan</creatorcontrib><creatorcontrib>Garabedian, Doreen</creatorcontrib><creatorcontrib>Jegaskanda, Sinthujan</creatorcontrib><creatorcontrib>Dowdell, Kennichi</creatorcontrib><creatorcontrib>Nguyen, Hanh</creatorcontrib><creatorcontrib>Laing, Kerry</creatorcontrib><creatorcontrib>Koelle, David</creatorcontrib><creatorcontrib>Azose, Aaron</creatorcontrib><creatorcontrib>Hunsberger, Sally</creatorcontrib><creatorcontrib>Lumbard, Keith</creatorcontrib><creatorcontrib>Chen, Aiying</creatorcontrib><creatorcontrib>Chang, Lee-Jah</creatorcontrib><creatorcontrib>Phogat, Sanjay</creatorcontrib><creatorcontrib>Cohen, Jeffrey</creatorcontrib><title>A Replication-Defective Herpes Simplex Virus (HSV)-2 Vaccine, HSV529, is Safe and Well-Tolerated in Adults with or without HSV Infection and Induces Significant HSV-2-Specific Antibody Responses in HSV Seronegative Individuals</title><title>Open forum infectious diseases</title><description>Abstract
Background
We conducted a phase 1, randomized, double-blind, placebo-controlled trial of a replication-defective HSV-2 vaccine, HSV529 (deleted for UL5 and UL29), in 60 healthy adults aged 18 to 40 years.
Methods
Subjects were enrolled in groups of 20 from 3 serogroups: HSV1+ or
-/HSV2+ (group 1), HSV1+/HSV2– (group 2), and HSV1-/HSV2– (group 3). At months 0, 1, and 6, 15 subjects in each group received HSV529 intramuscularly and 5 subjects received placebo. The primary endpoint was the frequency of solicited injection site and systemic reactions from day 0 to 7 after each vaccination and unsolicited adverse events up to 6 months after the last dose.
Results
89% of vaccine recipients experienced a mild to moderate solicited injection site reaction vs. 47% of placebo recipients (P = 0.006, 95% CI 0.129, 0.676) that did not preclude additional doses. 64% of vaccine recipients experienced solicited systemic reactions vs. 53% of placebo recipients (P = 0.44, 95% CI -0.179, 0.402). Two serious adverse events occurred in 2 participants and were assessed as unrelated to HSV529 administration. Serum neutralizing antibody titers significantly increased from baseline after 3 doses of HSV529 compared with placebo in group 3 only (P < 0.001). This increase persisted up to 6 months after the third dose of vaccine (P < 0.001). Serum and vaginal antibodies to HSV2 glycoprotein D (gD) also significantly increased after 3 doses of vaccine in group 3 subjects (P < 0.001 and P = 0.012, respectively). The mean vaginal gD titer after 3 doses was about one-third of the mean serum gD titer. In addition, the vaccine induced significant levels of HSV2-specific antibody dependent cellular cytotoxicity (ADCC) after 3 doses in group 3 subjects compared with placebo (P < 0.001). Vaccine-induced CD4 T-cell responses were detected in 46%, 27%, and 36% of subjects in groups 1, 2, and 3, respectively, one month after the third dose of vaccine. CD8 T-cell responses were detected in 8%, 18%, and 14% of subjects in groups 1, 2, and 3, respectively, at the same time point.
Conclusion
The HSV529 vaccine was safe, well-tolerated, and immunogenic, eliciting significant neutralizing, gD, and ADCC-mediating antibodies, and modest cellular immune responses in HSV seronegative individuals. NCT01915212
Disclosures
L. Dropulic, sanofi pasteur: Collaborator, Research support; K. Wang, sanofi pasteur: Collaborator, Research support; M. Oestreich, sanofi pasteur: Collaborator, Research support; H. Pietz, sanofi pasteur: Collaborator, Research support; D. Garabedian, sanofi pasteur: Collaborator, Research support; K. Dowdell, sanofi pasteur: Collaborator, Research support; H. Nguyen, sanofi pasteur: Collaborator, Research support; K. Laing, sanofi pasteur: Research Contractor, payment for conducting T cell assays; D. Koelle, sanofi pasteur: Research Contractor, payment for conducting T cell assays; A. Azose, sanofi pasteur: Research Contractor, Payment for conducting T cell assays; A. Chen, sanofi pasteur: Employee, Salary; L. J. Chang, sanofi pasteur: Employee, Salary; S. Phogat, sanofi pasteur: Employee, Salary</description><subject>Abstracts</subject><issn>2328-8957</issn><issn>2328-8957</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNqFUU1r3DAUNKWBhiT3HnVMaJRIlj8vgSVtswuBQB22R6GVnzYveCUj2dvk7_aXVPaGkp560UijmXkPJkk-c3bFWS2uncE2Hi-8EJHI-IfkOBVpRas6Lz--u39KzkJ4ZoxxznJW1sfJ7wX5AX2HWg3oLP0KBvSAeyBL8D0E0uCu7-CFrNGPgZwvm_UFTclaaY0WLkl852l9STAqlQGibEt-QtfRR9eBVwO0BC1ZtGM3BPILhyfi_IxuHCYzWdl5oLOzdWXbUc9TtxZNXMrOKprSpgc9MWRhB9y49jWuHXpnQ1THCVNUA95Z2Kp5_ZiEe2xH1YXT5MhEgLM3PEma798eb5f0_uFudbu4pzpNOadZVWkhykJXpShr4LzOStB15HhuIlcZVmXFpipYnulSK5MJIzRXm5wLocRJcnNI7cfNDloNdvCqk73HnfKv0imU__5YfJJbt5d5IViZixjADgHauxA8mL9ezuTUspxaloeW5dRytHw5WNzY_1_9BwqjrSc</recordid><startdate>20171004</startdate><enddate>20171004</enddate><creator>Dropulic, Lesia</creator><creator>Wang, Kening</creator><creator>Oestreich, Makinna</creator><creator>Pietz, Harlan</creator><creator>Garabedian, Doreen</creator><creator>Jegaskanda, Sinthujan</creator><creator>Dowdell, Kennichi</creator><creator>Nguyen, Hanh</creator><creator>Laing, Kerry</creator><creator>Koelle, David</creator><creator>Azose, Aaron</creator><creator>Hunsberger, Sally</creator><creator>Lumbard, Keith</creator><creator>Chen, Aiying</creator><creator>Chang, Lee-Jah</creator><creator>Phogat, Sanjay</creator><creator>Cohen, Jeffrey</creator><general>Oxford University Press</general><scope>TOX</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20171004</creationdate><title>A Replication-Defective Herpes Simplex Virus (HSV)-2 Vaccine, HSV529, is Safe and Well-Tolerated in Adults with or without HSV Infection and Induces Significant HSV-2-Specific Antibody Responses in HSV Seronegative Individuals</title><author>Dropulic, Lesia ; Wang, Kening ; Oestreich, Makinna ; Pietz, Harlan ; Garabedian, Doreen ; Jegaskanda, Sinthujan ; Dowdell, Kennichi ; Nguyen, Hanh ; Laing, Kerry ; Koelle, David ; Azose, Aaron ; Hunsberger, Sally ; Lumbard, Keith ; Chen, Aiying ; Chang, Lee-Jah ; Phogat, Sanjay ; Cohen, Jeffrey</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2211-488c3376c87379e11947ec9c3315f8738f0846b86054c7caf43f3c1ab5133a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Abstracts</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dropulic, Lesia</creatorcontrib><creatorcontrib>Wang, Kening</creatorcontrib><creatorcontrib>Oestreich, Makinna</creatorcontrib><creatorcontrib>Pietz, Harlan</creatorcontrib><creatorcontrib>Garabedian, Doreen</creatorcontrib><creatorcontrib>Jegaskanda, Sinthujan</creatorcontrib><creatorcontrib>Dowdell, Kennichi</creatorcontrib><creatorcontrib>Nguyen, Hanh</creatorcontrib><creatorcontrib>Laing, Kerry</creatorcontrib><creatorcontrib>Koelle, David</creatorcontrib><creatorcontrib>Azose, Aaron</creatorcontrib><creatorcontrib>Hunsberger, Sally</creatorcontrib><creatorcontrib>Lumbard, Keith</creatorcontrib><creatorcontrib>Chen, Aiying</creatorcontrib><creatorcontrib>Chang, Lee-Jah</creatorcontrib><creatorcontrib>Phogat, Sanjay</creatorcontrib><creatorcontrib>Cohen, Jeffrey</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Open forum infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dropulic, Lesia</au><au>Wang, Kening</au><au>Oestreich, Makinna</au><au>Pietz, Harlan</au><au>Garabedian, Doreen</au><au>Jegaskanda, Sinthujan</au><au>Dowdell, Kennichi</au><au>Nguyen, Hanh</au><au>Laing, Kerry</au><au>Koelle, David</au><au>Azose, Aaron</au><au>Hunsberger, Sally</au><au>Lumbard, Keith</au><au>Chen, Aiying</au><au>Chang, Lee-Jah</au><au>Phogat, Sanjay</au><au>Cohen, Jeffrey</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Replication-Defective Herpes Simplex Virus (HSV)-2 Vaccine, HSV529, is Safe and Well-Tolerated in Adults with or without HSV Infection and Induces Significant HSV-2-Specific Antibody Responses in HSV Seronegative Individuals</atitle><jtitle>Open forum infectious diseases</jtitle><date>2017-10-04</date><risdate>2017</risdate><volume>4</volume><issue>suppl_1</issue><spage>S415</spage><epage>S416</epage><pages>S415-S416</pages><issn>2328-8957</issn><eissn>2328-8957</eissn><abstract>Abstract
Background
We conducted a phase 1, randomized, double-blind, placebo-controlled trial of a replication-defective HSV-2 vaccine, HSV529 (deleted for UL5 and UL29), in 60 healthy adults aged 18 to 40 years.
Methods
Subjects were enrolled in groups of 20 from 3 serogroups: HSV1+ or
-/HSV2+ (group 1), HSV1+/HSV2– (group 2), and HSV1-/HSV2– (group 3). At months 0, 1, and 6, 15 subjects in each group received HSV529 intramuscularly and 5 subjects received placebo. The primary endpoint was the frequency of solicited injection site and systemic reactions from day 0 to 7 after each vaccination and unsolicited adverse events up to 6 months after the last dose.
Results
89% of vaccine recipients experienced a mild to moderate solicited injection site reaction vs. 47% of placebo recipients (P = 0.006, 95% CI 0.129, 0.676) that did not preclude additional doses. 64% of vaccine recipients experienced solicited systemic reactions vs. 53% of placebo recipients (P = 0.44, 95% CI -0.179, 0.402). Two serious adverse events occurred in 2 participants and were assessed as unrelated to HSV529 administration. Serum neutralizing antibody titers significantly increased from baseline after 3 doses of HSV529 compared with placebo in group 3 only (P < 0.001). This increase persisted up to 6 months after the third dose of vaccine (P < 0.001). Serum and vaginal antibodies to HSV2 glycoprotein D (gD) also significantly increased after 3 doses of vaccine in group 3 subjects (P < 0.001 and P = 0.012, respectively). The mean vaginal gD titer after 3 doses was about one-third of the mean serum gD titer. In addition, the vaccine induced significant levels of HSV2-specific antibody dependent cellular cytotoxicity (ADCC) after 3 doses in group 3 subjects compared with placebo (P < 0.001). Vaccine-induced CD4 T-cell responses were detected in 46%, 27%, and 36% of subjects in groups 1, 2, and 3, respectively, one month after the third dose of vaccine. CD8 T-cell responses were detected in 8%, 18%, and 14% of subjects in groups 1, 2, and 3, respectively, at the same time point.
Conclusion
The HSV529 vaccine was safe, well-tolerated, and immunogenic, eliciting significant neutralizing, gD, and ADCC-mediating antibodies, and modest cellular immune responses in HSV seronegative individuals. NCT01915212
Disclosures
L. Dropulic, sanofi pasteur: Collaborator, Research support; K. Wang, sanofi pasteur: Collaborator, Research support; M. Oestreich, sanofi pasteur: Collaborator, Research support; H. Pietz, sanofi pasteur: Collaborator, Research support; D. Garabedian, sanofi pasteur: Collaborator, Research support; K. Dowdell, sanofi pasteur: Collaborator, Research support; H. Nguyen, sanofi pasteur: Collaborator, Research support; K. Laing, sanofi pasteur: Research Contractor, payment for conducting T cell assays; D. Koelle, sanofi pasteur: Research Contractor, payment for conducting T cell assays; A. Azose, sanofi pasteur: Research Contractor, Payment for conducting T cell assays; A. Chen, sanofi pasteur: Employee, Salary; L. J. Chang, sanofi pasteur: Employee, Salary; S. Phogat, sanofi pasteur: Employee, Salary</abstract><cop>US</cop><pub>Oxford University Press</pub><doi>10.1093/ofid/ofx163.1041</doi><oa>free_for_read</oa></addata></record> |
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title | A Replication-Defective Herpes Simplex Virus (HSV)-2 Vaccine, HSV529, is Safe and Well-Tolerated in Adults with or without HSV Infection and Induces Significant HSV-2-Specific Antibody Responses in HSV Seronegative Individuals |
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